Revolade

Revolade

Manufacturer:

Novartis Oncology

Distributor:

DKSH
Concise Prescribing Info
Contents
Eltrombopag olamine
Indications/Uses
Treatment of chronic idiopathic thrombocytopenic purpura (ITP) to increase platelet counts & reduce or prevent bleeding. Patients w/ chronic HCV infections for the treatment of thrombocytopenia. Treatment of cytopenias in patients w/ severe aplastic anemia (SAA).
Dosage/Direction for Use
Individualized dosage based on patient's platelet count. Immune thrombocytopenia Adult & ped 6-17 yr Starting dose: 50 mg once daily. Max: 75 mg daily. Ped 1-5 yr Starting dose: 25 mg once daily. Chronic HCV-associated thrombocytopenia Adult Starting dose: 25 mg once daily. Should be adjusted in 25-mg increments every 2 wk to achieve target platelet count. Max dose: 100 mg once daily. 1st-line severe aplastic anemia (concurrently w/ standard immunosuppressive therapy) Adult & ped 12-17 yr 150 mg once daily for 6 mth. Ped 6-11 yr 75 mg once daily for 6 mth, 2-5 yr 2.5 mg/kg once daily for 6 mth. SAA patient of East-/Southeast-Asian ancestry May start w/ ½ of recommended dosage. Refractory severe aplastic anemia Adult Initially 50 mg once daily. Max dose: 150 mg once daily. Hepatic impairment & Asian ancestry Initially 25 mg once daily.
Administration
Should be taken on an empty stomach: Take at least 2 hr before or 4 hr after antacids, dairy products or mineral supplements containing polyvalent cations (eg, Al, Ca, Fe, Mg, Se, Zn).
Special Precautions
Not established for use in other thrombocytopenic conditions. Measure serum ALT, AST & bilirubin prior to initiation of treatment 2 wkly during dose adjustment phase & mthly following establishment of stable dose. Hepatic disease. Known risk factors for thromboembolism. Not for treatment of thrombocytopenia in patients w/ chronic liver disease in prep for invasive procedures. Closely monitor complete blood counts including platelet counts & peripheral blood smear. Malignancies & progression of malignancies. Cataracts. May interfere w/ serological testing. Pregnancy & lactation. Elderly ≥65 yr.
Adverse Reactions
Adult ITP: Pharyngitis; diarrhoea, nausea, vomiting, dry mouth; cataract; increased AST & ALT, hyperbilirubinaemia; alopecia, rash; back pain, musculoskeletal pain, myalgia, thromboembolic events, thrombotic microangiopathy w/ acute renal failure. Ped ITP: Upper resp tract infection, nasopharyngitis; cough, oropharyngeal pain, rhinorrhoea; abdominal pain, toothache; pyrexia. HCV in combination w/ interferon therapy: Anaemia; decreased appetite; headache; cataract; nausea, diarrhoea; hyperbilirubinaemia, hepatic failure, drug-induced liver injury; pruritus, alopecia, rash; myalgia; fatigue, pyrexia, chills, asthenia, oedema, flu-like illness; thromboembolic events. SAA: Headache; cataract; oropharyngeal pain, cough, rhinorrhoea; nausea, diarrhoea, abdominal pain; increased transaminases, hypebilirubinaemia; rash; arthralgia, pain in extremity, muscle spasms; fatigue, dizziness, pyrexia.
Drug Interactions
Decreased Cmax & AUC w/ cyclosporine. Decreased plasma eltrombopag & Cmax w/ polyvalent cations (chelation) eg, antacids, dairy products & other products containing polyvalent cations eg Al, Ca, Fe, Mg, selenium, Zn (administer at least 2 hr before or 4 hr after). Decreased conc w/ lopinavir/ritonavir. May increase plasma conc of rosuvastatin & other OATP1B1 & BCRP substrates.
MIMS Class
Haemostatics
ATC Classification
B02BX05 - eltrombopag ; Belongs to the class of other systemic hemostatics. Used in the treatment of hemorrhage.
Presentation/Packing
Form
Revolade FC tab 25 mg
Packing/Price
2 × 7's
Form
Revolade FC tab 50 mg
Packing/Price
2 × 7's
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